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Completed

NCT Number: NCT03708640

mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)

This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.

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Key information

Conditions

HIV Behavior Frailty Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 positive adults of any gender
  • Age 50 years and older
  • Frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength)
  • Ability to provide informed consent

Exclusion criteria

  • Any physical condition that would prevent or prohibit moderate physical activity
  • >3 days per week of moderate or vigorous leisure time activity lasting >30 min/day

Treatment and study plan

Digital Activity Tracker

Other

Group wears physical activity tracker and receives physical activity feedback information informed by the tracker

Smart Text Messaging

Other

Group receives personalized, health coaching via "smart" text messages

Physical activity counseling

Other

Group receives baseline counseling on physical activity

Primary outcomes

  1. Change in Mean daily step count

    Time frame: Baseline, 12 weeks

    Mean daily step count will be assessed using a digital physical activity tracker

Secondary outcomes

  1. Change in Frailty as assessed by the Fried-based physical frailty phenotype

    Time frame: Baseline, 12 weeks

    Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity)

  2. Change in Physical Fitness as assessed by 12 minute walk

    Time frame: Baseline, 12 weeks

    Physical fitness of participants will be assessed by the ability to do a 12 minute walk

  3. Change in Muscle strength as assessed by isokinetic resistance

    Time frame: Baseline, 12 weeks

    Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs)

  4. Percent change in fat mass

    Time frame: Baseline, 12 weeks

    Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan

  5. Percent change in lean mass

    Time frame: Baseline, 12 weeks

    Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan

  6. Change in Physical performance as assessed by the physical performance battery

    Time frame: Baseline, 12 weeks

    Physical performance evaluated with the short physical performance battery

  7. Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)

    Time frame: Baseline, 12 weeks

    The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive measure of health-related quality of life. The 35-item questionnaire includes 10 dimensions (pain, physical, role, health perceptions, social and cognitive functioning, energy, mental health, health distress and quality of life). Each dimension is scored on a 0-100 scale (a higher score indicates better health related quality of life). An overall score is obtained through a summation of z scores from each domain.

  8. Change in Interleukin-6 (IL-6) concentration

    Time frame: Baseline, 12 weeks

    Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change

  9. Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)

    Time frame: Baseline, 12 weeks

    sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2018
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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